Imaging Operations Manager, Clinical Studies

Novartis; City Of London; Hybrid; GBP 70,000 - 95,000; Full time

Job summary

A leading pharmaceutical company is seeking an Imaging Operations Manager to oversee the operational implementation of imaging strategies for clinical studies. The role involves vendor management, coordinating study teams, and ensuring compliance with regulations in a hybrid work environment. Ideal candidates will have an advanced degree and considerable experience in trial vendor management, especially in imaging.

Qualifications

• Experience in trial vendor management, ideally in Imaging.
• Excellent knowledge of clinical trial design and supplier requirements.
• Strong problem-solving and solution generation skills.

Responsibilities

• Review vendor-related protocol sections for studies.
• Coordinate vendor kick-off meetings and manage interfaces.
• Monitor vendor service excellence and adherence to standards.

Skills

Trial vendor management

Clinical operation processes

GxP and ICH regulations

Root cause analysis

Fluent English

Education

Advanced degree in science or business

Job description

Job Description Summary

Internal job title: Imaging Operations Manager
Location: London (UK) or Dublin (Ireland)

As Imaging Operations Manager (IOM) you will be responsible for the operational implementation of the imaging strategy for assigned clinical studies in close collaboration with the Clinical Trial Team (CTT). You may support the full study lifecycle and/or contribute directly to the study sub-team(s).

In this role you will enable a flawless and accelerated vendor service delivery at the trial start-up phase and support implementation of defined category strategies and service standardization. You proactively assess risk and conclude contingency plans to de-risk study startup and milestones.

This position is part of VP&G (Vendor Partnership & Governance) Vendor Alliance Imaging team and reports directly to the Vendor Alliance Lead Associate Director.

It is a hybrid position and requires regular presence on site.

Job Description

Key Responsibilities:

• Reviewing of the vendor and category related specific sections of the protocol, ensuring vendor expertise is leveraged when refining specifications towards Final Protocol
• Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors, incl. reviewing Quote/Proposal review in collaboration with procurement (and vendor), supporting contract negotiations and budget review
• Co-ordinating vendor kick-off meeting, managing the imaging vendor interface with the study team, including leading vendor meetings, driving preparation of key documents, tracking adherence of critical vendor milestones
• Ensuring changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications. Supports amendment of vendor contracts with Procurement team
• Optimizing a frontloaded and timely study start-up (SSU) process in support of a timely vendor database (DB)-go-live
• Monitoring vendor service excellence at study level, ensuring vendors meet quality and service level standards in their service delivery for the trial
• Pro-actively creating and maintaining vendor related risk maps with contingency plan for documentation in company tool, documenting there also issues identified with vendor oversight / performance, implementing and monitoring corrective actions, escalating issues if required to the Vendor Alliance Lead (VAL).
• Supporting the implementation of standards, templates, tools, and processes for vendors at SSU for defined categories in collaboration with the VAL. Driving root cause analysis of supplier performance issues and look for trending, supporting practice leaders in improvement projects and learning loops
• Participating in the onboarding, mentoring, and training of new staff as applicable to specific category
• In partnership with the vendor, developing site and monitor training material, and attend/support training if needed

Minimum Requirements:

• Advanced degree in science or business with experience in trial vendor management, ideally in the category Imaging
• Fluent English, oral and written
• Solid working experience and excellent knowledge of the clinical operation processes and vendor management
• Excellent knowledge of GxP and ICH regulations
• Expert knowledge of clinical trial design and mapping to supplier requirements
• Demonstrated leadership with supplier relationship service areas management and/or expert knowledge of specific
• Demonstrated partnering across divisions with internal and external stakeholders
• Demonstrated root cause analysis, problem solving, and solution generation skills
• Knowledge of key deliverables that impact green light milestones and vendor readiness
• Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (RFP, RFQ, contracting)

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

Equal Employment Opportunity (EEO) Statement: Novartis is an equal opportunities employer and welcomes applications from all qualified candidates.